Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

EBG 2016-01-19

DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR

Applicant Dentalplus GmbH

K-Number K152215

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GEX 2016-01-19

Lustre PRO Light System

Applicant Ambicare Health, Ltd.

K-Number K143713

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OVE 2016-01-19

Unison-C Anterior Cervical Fixation System

Applicant Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

K-Number K152793

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OZT 2016-01-19

True Flow Valvuloplasty Perfusion Catheter

Applicant C.R. Bard, Inc.

K-Number K152613

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DWF 2016-01-15

Medtronic Bio-Medicus Adult Cannula Kit

Applicant Medtronic, Inc.

K-Number K153598

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LON 2016-01-15

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml

Applicant Becton, Dickinson and Company

K-Number K151320

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JDQ 2016-01-15

Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System

Applicant Zimmer, Inc.

K-Number K151848

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KGO 2016-01-15

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm

Applicant Emerson & Co. Srl

K-Number K151228

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NUJ 2016-01-15

Reprocessed Vessel Sealer

Applicant Sterilmed, Inc.

K-Number K152134

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HTW 2016-01-15

Renovo Life Hard Carbon Coated Drill Bit

Applicant Renovo Life, LLC

K-Number K151661

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LHC 2016-01-15

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes

Applicant Ecolab, Inc.

K-Number K152522

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NAY 2016-01-15

da Vinci Xi Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K151794

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